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Medline

IEC 62304 Software Verification & Compliance Program

Garrett Technologies, Inc. supported Medline through a comprehensive software verification effort aligned with IEC 62304 for Class B software. The initiative included risk analysis review, gap remediation, lifecycle documentation, and full verification protocol development—culminating in successful design transfer and compliance-ready documentation.

Garrett provided a structured, traceable path from gap analysis through final sign-off, ensuring Medline’s embedded software met regulatory expectations for safety, documentation, and software reliability, helping Medline meet IEC 62304 requirements with complete software verification and documentation—delivering a system ready for clinical use and regulatory clearance.

WE DELIVERED

  • · Software safety class B designation with justification and documented risk analysis

    
· Gap analysis using 62304 checklist with DHF and documentation review

    
· Full suite of lifecycle documents: SCMP, V&V Plan, Maintenance & Problem Resolution Plans


    · Software architecture and design description with traceable requirement authoring

    
· Software integration plan covering SOUP components (FreeRTOS, Ramtex GUI, ST drivers)


    · Test protocol authoring and execution for unit, integration, and system-level testing

    
· Software verification with regression testing and anomalies list (Jira/Bugzilla compatible)


    · Traceability matrix generation and review cycle with QA and client teams


    · Risk mitigation review, hazard analysis, and FMEA traceability


    · Software drop preparation and verification execution coordination

    
· Final documentation and reports, with stakeholder signoffs and DHF updates


    · Formal design transfer to Medline with support for regulatory inspection readiness